News

RICHMOND, VA, UNITED STATES, December 11, 2024 /EINPresswire.com/ — Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Versus™ Catheter.

This innovative medical device is set to enhance the treatment of pulmonary artery blood clots by offering real-time pulmonary artery pressure measurements, empowering clinicians to optimize treatment based on individual patient responses. This novel technology enables a new treatment category called “Hemodynamics-Led Thrombolysis (HLT).”

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (60 Degrees Pharmaceuticals or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients.

ANNAPOLIS, MD – Governor Wes Moore today announced that applications are being accepted for the Maryland Soft Landing Exchange Program, which allows Maryland companies to explore international markets at a reduced cost by connecting them with business incubators and accelerators abroad. The program, administered by the Maryland Department of Commerce, is designed to support companies who are ready to expand their existing export capabilities, and serves as an important enhancement to existing state export assistance.

Emmes®, part of Emmes Group®, a leading specialty tech and AI-enabled global contract research organization (CRO), today announced the appointment of Bryan Patterson to the newly created role of Senior Vice President, Government Business Development & Capture. This strategic expansion of Emmes’ leadership team underscores the company’s commitment to the U.S. Federal Government clinical research efforts, and to exceed expectations, drive innovation, and deliver even greater value.

GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ — Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US.

The OASIS trial was approved by the FDA earlier this year to assess the safety and efficacy of OsteoAdapt™ SP, Theradaptive’s implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.

On December 4th, TEDCO hosted its 10th Entrepreneur Expo in Baltimore, bringing together over 1,000 entrepreneurs, investors, and industry leaders for a day of connection, learning, and celebration. As a premier event in Maryland, the Expo showcased the state’s vibrant entrepreneurial ecosystem through workshops, roundtable discussions, and exhibitions, featuring 95 speakers and 84 companies, including 34 startups. The BioHealth Innovation, Inc. (BHI) team was proud to participate in this dynamic gathering, further strengthening its commitment to fostering growth and commercialization in the BioHealth Capital Region.

BELTSVILLE, Md., Dec. 10, 2024 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.

ANNAPOLIS, Md., Dec. 10, 2024 /PRNewswire/ —  Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration’s (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.